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tianya716
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中文翻译成英文--翻译文章的摘要 自己翻译了一点，但觉得自己水平太差，需要帮助！ 很急！！因为文章就要送审了，自己已经在上班，时间太少。 摘要 目的 本课题研制瑞格列奈分散片，目的是提高药物的生物利用度、提高顺应性和建立科学严谨的质量控制标准。研制的瑞格列奈分散片已经转让与**制药公司进行临床试验和上市销售。本文研制的瑞格列奈自微乳胶囊，目的是进一步提高药物的生物利用度和减少药物可能存在的副作用。 方法（1）瑞格列奈分散片处方和工艺研究 采用单因素试验，以分散均匀性和溶出度为指标，对辅料种类的进行筛选；采用正交试验，以分散均匀性、溶出度为指标，对辅料用量进行优化，并最终确定处方。采用单因素试验对等量递增混匀法-湿法制粒工艺、溶剂分散混匀法-湿法制粒工艺和等量递增混匀法-粉末直接压片工艺，进行比较，优选出最佳的工艺。 （2）瑞格列奈分散片含量测定方法的研究 以回收率和pH耐用性为评价指标，对三种瑞格列奈片剂的含量测定方法进行比较，最终确定美国药典的瑞格列奈片剂的含量测定方法较好。并依据美国药典的瑞格列奈片剂的含量测定方法，建立了瑞格列奈分散片的含量测定方法。 （3）瑞格列奈分散片溶出度测定方法的研究 通过对瑞格列奈分散片溶出介质和转速的筛选，建立了科学合理的溶出度测定方法，并对瑞格列奈分散片进行了体外评价研究。 （4）瑞格列奈分散片有关物质的研究 通过酸、碱、热破环试验，对瑞格列奈可能存在有关物质进行分离，并通过二极管阵列检测器对药物主峰的纯度进行检查，建立科学严谨的瑞格列奈和瑞格列奈分散片的有关物质的测定方法。 （5）瑞格列奈分散片的加速稳定性考察 对瑞格列奈分散片进行了6个月的加速稳定性试验，并据此预测出药物的有效期为2年。 （6）瑞格列奈自微乳胶囊的研制 采用正交试验和三元相图，以溶解度、透光率、粒径指标，筛选瑞格列奈自微乳胶囊的处方，并进行质量评价研究和初步稳定性考察。 结果 （1）瑞格列奈分散片 成功优选出瑞格列奈分散片的处方，并建立了科学严谨的质量标准。自制瑞格列奈分散片比市售的普通片剂的溶出速率和30min的溶出度均明显增加，初步达到提高药物生物利用度的目的。 （2）瑞格列奈自微乳胶囊 成功优选出瑞格列奈自微乳胶囊的处方，并建立了质量控制和评价标准。瑞格列奈自微乳胶囊，与市售的普通片剂和自制的普通胶囊相比，溶出速率和30min的溶出度均明显增加，初步达到提高药物生物利用度的目的。 结论 筛选的瑞格列奈分散片和自微乳胶囊的处方合理，制备工艺简单可行，质量标准能有效控制质量。制备的瑞格列奈分散片和自微乳胶囊符合制剂质量要求。通过体外评价研究，所研制的瑞格列奈分散片和自微乳胶囊，与市售的普通片剂和普通胶囊相比，溶出明显加快，初步达到提高药物生物利用度的目的。 关键词：瑞格列奈；分散片；自微乳胶囊；正交试验；质量标准；三元相图；星点-效应面设计 Abstract Objective The purpose of this subject is developping repaglinide dispersible tablets, aims to improve the bioavailability of drugs, improve compliance and the establishment of scientific and strict quality control standards. Repaglinide dispersible tablets have been sold to the U.S. **Zhongshan pharmaceutical company. This article developed the microemulsion capsule of repaglinide, aims to further improve the bioavailability of the drug and reduce drug side effects that may exist. Methods (1) repaglinide dispersible tablets prescription and technology [ Last edited by tianya716 on 2010-5-18 at 18:36 ] |
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tianya716 
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3楼2010-05-18 19:40:32
mmyytiger
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tianya716(金币+3, 翻译EPI+1):貌是工具翻译的 2010-05-18 22:23:13
sirljz:禁止工具直接翻译的回帖 2010-05-20 17:32:32
sirljz:禁止工具直接翻译的回帖 2010-05-20 17:32:32
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Abstract objective The purpose of this subject develop repaglinide, dispersible tablets, aims to improve the bioavailability of drugs, improve compliance and the establishment of scientific and strict quality control standards. Repaglinide dispersible tablets have been developed and ** transfer clinical trials and pharmaceutical companies on sale. This article developed from the microemulsion capsule repaglinide, aims to further improve the bioavailability of drugs and reduce drug side effects that may exist. Methods (1) repaglinide tablet formulation and technology of single factor experiments to spread the uniformity and dissolution rate as an index of the types of screening accessories; orthogonal test, to spread uniformity, dissolution rate for the index for accessories to optimize the dosage and ultimately determine the prescription. Single-factor test and the equivalent incremental mixing method - wet granulation process, solvent dispersion mixing method - wet granulation process and the equal incremental mixing method - the powder pellets technology, comparing the optimized process . (2) Determination of repaglinide tablet study to recovery and durability for the evaluation of pH indicator, the three methods the determination of repaglinide tablets compared to finalize the United States Pharmacopoeia repaglinide Determination tablets better. And according to the United States Pharmacopoeia method for the determination of repaglinide tablets, dispersible tablets was established method for the determination of repaglinide. (3) determination of repaglinide in tablet dissolution studies on repaglinide tablet dissolution medium and the speed of screening, the establishment of a scientific and reasonable method of dissolution test, and repaglinide were dispersible tablets In vitro evaluation. (4) repaglinide tablet related substances by acid, alkali, heat broken ring test, the material on repaglinide may be isolated by diode array detector and the main peak of the purity of the drug inspection, the establishment of rigorous science and repaglinide repaglinide tablet Determination of related substances. (5) the acceleration of dispersible tablets stability of repaglinide on repaglinide tablet was 6 months of accelerated stability test, and to predict the drug is valid for 2 years. (6) repaglinide from microemulsion capsule by orthogonal experiment and the ternary phase diagram, with solubility, light transmittance, particle size index, selection repaglinide from microemulsion capsule formulation, and evaluated the quality of Stability study and preliminary. Results (1) successfully optimized repaglinide repaglinide tablet dispersible tablets prescription, and the establishment of a scientific rigorous quality standards. Home Repaglinide dispersible tablets compared with ordinary commercial dissolution rate and dissolution of 30min were significantly increased, initially to improve drug bioavailability purposes. (2) of repaglinide from microemulsion capsule successfully optimized microemulsion capsules from prescription repaglinide, and the establishment of quality control and evaluation criteria. Repaglinide from microemulsion capsule, and general commercial and home-made capsules, tablets compared, the release rate and the dissolution of 30min were significantly increased, initially to improve drug bioavailability purposes. Conclusion screening repaglinide tablet and capsule from the microemulsion reasonable prescription, preparation is simple and feasible, effective quality control quality standards. Preparation of repaglinide tablet and capsule from the microemulsion formulation meet quality requirements. In vitro evaluation studies, the development of repaglinide in tablet and capsule from the microemulsion, with commercially available conventional tablets and capsules, compared to significantly speed up the dissolution, initially to improve drug bioavailability purposes. Keywords: Repaglinide; tablet; from microemulsion capsule; orthogonal test; quality standards; ternary phase diagram; Star points - response surface design |
2楼2010-05-18 18:44:13
benmao_mogu
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4楼2010-05-18 19:44:50
tianya716
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5楼2010-05-18 21:15:50
